Detection and treatment of cancer in early stages of tissue malignancy can lead to a favorable result if metastasis has not already occurred. In contrast, misdiagnosis and in particular false positive and over diagnosis, often lead to unnecessary further testing and/or treatment that can be costly and harmful, resulting in pain and mental anguish for the patient but often with little or no decrease in cancer mortality rates.
The conventional approach to determining cancer size (such as before and after treatment) and their change or growth rate are just linear measurements of a single maximum dimension as illustrated in FIGS. 1A through 1D for the approved and widely used and criticized Response Evaluation Criteria In Solid Tumors (RECIST) technique and a modified RECIST technique signified by mRECIST. FIGS. 1A and 1B are before and after treatment contrast enhanced computed tomography (CT) images of a cancer nodule in a liver evaluated using a standard RECIST technique. FIGS. 1C and 1D are before and after treatment contrast enhanced CT images of the cancer nodule of FIGS. 1A and 1B evaluated using a modified RECIST technique. The diverse results obtained with the RECIST and mRECIST techniques are shown in the plot of FIG. 2. FIG. 2 is a waterfall plot of treatment response data for a number of live cancer patients evaluated using RECIST and modified RECIST techniques. The major disadvantage of these approaches are that they underutilizes the advances from modern three dimensional (3D) CT and magnetic resonance imaging (MRI) due to the latter's current inabilities to reliably determine the transition boundaries where surfaces of malignant tissues switch to healthy normal ones.
Accordingly, there is a need for a method of detecting and determining solid cancer size and size changes utilizing contrast enhanced MRI and CT imaging that provides improved determination of transition boundaries and changes in cancer size.